Prescribing Information
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LAMICTAL Lamotrigine QUALITATIVE AND QUANTITATIVE COMPOSITION LAMICTAL Tablets: Each film-coated tablet contains 25, 50 and 100 mg lamotrigine. LAMICTAL Dispersible/Chewable Tablets: Each tablet contains 5 mg lamotrigine, which may be chewed, dispersed in a liquid or swallowed whole. CLINICAL INFORMATION Indications EPILEPSY • Adults and Adolescents (over 12 years of age) LAMICTAL is indicated for use as adjunctive or monotherapy in the treatment of epilepsy, for partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut syndrome. • Children (2 to 12 years of age) LAMICTAL is indicated as adjunctive therapy in the treatment of epilepsy, for partial seizures and generalised seizures including tonic-clonic seizures and the seizures associated with Lennox-Gastaut syndrome. Initial monotherapy treatment in newly diagnosed paediatric patients is not recommended. After epileptic control has been achieved during adjunctive therapy, concomitant anti- epileptic drugs (AEDs) may be withdrawn and patients continued on LAMICTAL monotherapy. LAMICTAL 2 mg dispersible/chewable tablet is not available locally. If the calculated dose in children is less than 2.5 mg daily, then LAMICTAL cannot be used. DO NOT attempt to administer partial quantities of the dispersible/chewable tablets. BIPOLAR DISORDER • Adults (18 years of age and over) 1 LAMICTAL is indicated for the prevention of depressive episodes in patients with bipolar disorder. Safety and efficacy of LAMICTAL in the acute treatment of mood episodes has not been established. The physician who elects to use LAMICTAL for periods extending beyond 18 months should periodically re-evaluate the long-term usefulness of the drug for the individual patient. Dosage and Administration Pharmaceutical form: Tablets and Dispersible/Chewable tablets LAMICTAL tablets should be swallowed whole, and should not be chewed or crushed. LAMICTAL dispersible/chewable tablets may be chewed, dispersed in a small volume of water (at least enough to cover the whole tablet) or swallowed whole with a little water. DO NOT attempt to administer partial quantities of the dispersible/chewable tablets. If a calculated dose of LAMICTAL, e.g. for use in children (epilepsy only) or patients with hepatic impairment, cannot be divided into multiple lower strength tablets, the dose to be administered is that equal to the nearest lower strength of whole tablets. It is strongly recommended that therapy with lamotrigine is initiated at the recommended doses. Careful incremental titration of the dose may decrease the severity of skin rashes. There are suggestions, yet to be proven, that the risk of severe, potentially life- threatening rash may be increased by co-administration of LAMICTAL with valproate. However, cases have been reported in the absences of these factors. Therefore, it is important that the dosing recommendations be followed closely. Restarting Therapy Prescribers should assess the need for escalation to maintenance dose when restarting LAMICTAL in patients who have discontinued LAMICTAL for any reason, since the risk of serious rash is associated with high initial doses and exceeding the recommended dose escalation for LAMICTAL (see Warnings and Precautions). The greater the interval of time since the previous dose, the more consideration should be given to escalation to the maintenance dose. When the interval since discontinuing LAMICTAL exceeds five half- lives (see Pharmacokinetics), LAMICTAL should generally be escalated to the maintenance dose according to the appropriate schedule. It is recommended that LAMICTAL not be restarted in patients who have discontinued due to rash associated with prior treatment with LAMICTAL unless the potential benefit clearly outweighs the risk. EPILEPSY When concomitant anti-epileptic drugs are withdrawn to achieve LAMICTAL monotherapy or other AEDs are added on to treatment regimes containing lamotrigine, consideration should be given to the effect this may have on lamotrigine pharmacokinetics (see Interactions). 2 • Adults and Adolescents (over 12 years of age) (see Table 1) Dosage in Epilepsy Monotherapy The initial LAMICTAL dose in monotherapy is 25 mg once a day for two weeks, followed by 50 mg once a day for two weeks. Thereafter, the dose should be increased by a maximum of 50 to 100 mg every one to two weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 100 to 200 mg/day given once a day or as two divided doses. Some patients have required 500 mg/day of LAMICTAL to achieve the desired response. Because of a risk of rash the initial dose and subsequent dose escalation should not be exceeded (see Warnings and Precautions). Dosage in Epilepsy Add-On Therapy In patients taking valproate with/without any other AED, the initial LAMICTAL dose is 25 mg every alternate day for two weeks, followed by 25 mg once a day for two weeks. Thereafter, the dose should be increased by a maximum of 25 to 50 mg every one to two weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 100 to 200 mg/day given once a day or in two divided doses. In those patients taking concomitant AEDs or other medications (see Interactions) that induce lamotrigine glucuronidation with/without other AEDs (except valproate), the initial LAMICTAL dose is 50 mg once a day for two weeks, followed by 100 mg/day given in two divided doses for two weeks. Thereafter, the dose should be increased by a maximum of 100 mg every one to two weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 200 to 400 mg/day given in two divided doses. Some patients have required 700 mg/day of LAMICTAL to achieve the desired response. In those patients taking other medications that do not significantly inhibit or induce lamotrigine glucuronidation (see Interactions), the initial LAMICTAL dose is 25 mg once a day for two weeks, followed by 50 mg once a day for two weeks. Thereafter, the dose should be increased by a maximum of 50 to 100 mg every one to two weeks until the optimal response is achieved. The usual maintenance dose to achieve an optimal response is 100 to 200 mg/day given once a day or as two divided doses. 3 Table 1: Recommended treatment regimen in EPILEPSY for adults and adolescents over 12 years of age Treatment regimen Weeks 1 - 2 Weeks 3 - 4 Maintenance Dose 25 mg 50 mg 100 – 200 mg (once a day) (once a day) (once a day or two divided doses) Monotherapy To achieve maintenance, doses may be increased by 50 – 100 mg every one to two weeks 12.5 mg 25 mg 100 – 200 mg (given 25 mg (once a day or two divided Add-on therapy with valproate (once a day) regardless of any concomitant alternate days) doses) medications To achieve maintenance, doses may be increased by 25 – 50 mg every one to two weeks This dosage regimen 50 mg 100 mg 200 – 400 mg should be used with: (once a day) (two divided (two divided doses) Phenytoin doses) Carbamazepine To achieve maintenance, doses Phenobarbitone may be increased by 100 mg Primidone every one to two weeks Or with other inducers of Add-on lamotrigine therapy glucuronidation (see without Interactions) valproate This dosage regimen 25 mg 50 mg 100 – 200 mg should be used with other medications that (once a day) (once a day) (once a day or two divided do not significantly doses) inhibit or induce lamotrigine To achieve maintenance, doses glucuronidation (see may be increased by 50 – Interactions) 100 mg every one to two weeks In patients taking AEDs where the pharmacokinetic interaction with lamotrigine is currently not known (see Interactions), the treatment regimen as recommended for LAMICTAL with concurrent valproate should be used. 4 Because of a risk of rash the initial dose and subsequent dose escalation should not be exceeded (see Warnings and Precautions). • Children (2 to 12 years of age) (see Table 2) In patients taking valproate with/without any other AED, the initial LAMICTAL dose is 0.15 mg/kg bodyweight/day given once a day for two weeks, followed by 0.3 mg/kg/day once a day for two weeks. Thereafter, the dose should be increased by a maximum of 0.3 mg/kg every one to two weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 1 to 5 mg/kg/day given once a day or in two divided doses, with a maximum of 200 mg/day. In those patients taking concomitant AEDs or other medications (see Interactions) that induce lamotrigine glucuronidation with/without other AEDs (except valproate), the initial LAMICTAL dose is 0.6 mg/kg bodyweight/day given in two divided doses for two weeks, followed by 1.2 mg/kg/day given in two divided doses for two weeks. Thereafter, the dose should be increased by a maximum of 1.2 mg/kg every one to two weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 5 to 15 mg/kg/day given once a day or in two divided doses, with a maximum of 400 mg/day. To ensure a therapeutic dose is maintained the weight of a child must be monitored and the dose reviewed as weight changes occur. Table 2: Recommended treatment regimen in EPILEPSY for children aged 2-12 years (total daily dose in mg/kg bodyweight/day) on combined drug therapy ** Treatment regimen Weeks 1 - 2 Weeks 3 - 4 Maintenance Dose 0.15 mg/kg* 0.3 mg/kg 0.3 mg/kg increments every one to two weeks to achieve a Add-on therapy with valproate maintenance dose of 1 – 5 regardless of any other (once a day) (once a day) mg/kg (once a day or two concomitant medication divided doses) to a maximum of 200 mg/day.